BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 9556709 · Received January 7, 2020

    Report

    Report Number
    3002124543-2019-00071
    Event Type
    Death
    Date Received
    January 7, 2020
    Date of Event
    October 1, 2018
    Report Date
    December 17, 2019
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    KRD
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. BTG MEDICAL ASSESSMENT: DATE UNKNOWN: DC BEADS WERE USED FOR TREATMENT OF HEPATOCELLULAR CARCINOMA (HCC) AT UNIVERSITY S. (B)(6) 2018: THE PATIENT HAD A TUMOUR RUPTURE-LIKE CONDITION, WHICH LED TO MASSIVE HAEMORRHAGE. AS A RESULT, THE PATIENT DIED. NO FURTHER INFORMATION WAS AVAILABLE, AND INVESTIGATION WAS ONGOING AT UNIVERSITY S FOR DETAILED INFORMATION. MASSIVE HAEMORRHAGE LEADING TO DEATH. SEVERITY 4; SERIOUS; ANTICIPATED; CAUSALITY: POSSIBLY DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO ENABLE FURTHER INVESTIGATION AS FOLLOWS BUT HAS NOT BEEN RECEIVED TO DATE: IMPLANT DATE. BATCH NUMBER OF THE DEVICE. WERE THE BEADS DRUG LOADED? IS SO WITH WHAT? PATIENT MEDICAL HISTORY INCLUDING CONCOMITANT THERAPY AND COMORBIDITIES. PATIENT AGE, SEX. ANY INVESTIGATION FINDINGS FROM THE UNIVERSITY. BLEEDING OF THE TUMOUR (HAEMORRHAGE) IS AN ANTICIPATED ADVERSE EVENT LISTED IN THE IFU HAEMORRHAGE (VESSEL OR LESION RUPTURE) AND DEATH ARE ANTICIPATED EVENTS LISTED IN THE RISK MANAGEMENT DOCUMENTATION. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE BATCH NUMBER HAS NOT BEEN PROVIDED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. NO CORRECTIVE/PREVENTATIVE ACTION HAS BEEN IDENTIFIED. SHOULD WE RECEIVE ANY INFORMATION TO ENABLE FURTHER INVESTIGATIONS, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 1

    DATE UNKNOWN: DC BEADS WERE USED FOR HEPATOCELLULAR CARCINOMA (HCC) AT UNIVERSITY S. (B)(6) 2018: THE PATIENT HAD A TUMOUR RUPTURE-LIKE CONDITION, WHICH LED TO MASSIVE HAEMORRHAGE. AS A RESULT, THE PATIENT DIED. NO FURTHER INFORMATION WAS AVAILABLE, AND INVESTIGATION WAS ONGOING AT UNIVERSITY S FOR DETAILED INFORMATION. AE: CAUSALITY/ SERIOUSNESS (PHYSICIAN). DEATH: PROBABLY RELATED/ SERIOUS. CONCOMITANT DISEASE: UNKNOWN. PAST MEDICAL HISTORY: UNKNOWN. CONCOMITANT DRUGS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23491 DC BEAD HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD KRD BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death